EFFICACY, TOLERABILITY AND SAFETY OF AN ORAL ENZYME COMBINATION VS. DICLOFENAC IN OSTEOARTHRITIS OF THE KNEE – RESULTS OF AN INDIVIDUAL PATIENT-LEVEL POOLED RE-ANALYSIS OF DATA FROM SIX RANDOMIZED CONTROLLED TRIALS

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/12248
• EU PAS number:
  EUPAS12247
• Study ID:
  12248
• Official title and acronym:
  EFFICACY, TOLERABILITY AND SAFETY OF AN ORAL ENZYME COMBINATION VS. DICLOFENAC IN OSTEOARTHRITIS OF THE KNEE – RESULTS OF AN INDIVIDUAL PATIENT-LEVEL POOLED RE-ANALYSIS OF DATA FROM SIX RANDOMIZED CONTROLLED TRIALS
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Individual patient-level pooled re-analysis of patient-reported data from prospective, randomized, double-blind parallel-group studies in adult patients with moderate to severe OA of the knee treated for at least 3 weeks with OEC or DIC. Appropriate trials will be identified with a systemic literature and database research. Data will be extracted from the original case report forms and re-analysed by a blinded evaluation committee. Primary endpoint is the improvement of Lequesne´s algofunctional index (LAFI) score at study end vs. baseline. Secondary endpoints address LAFI response rates, treatment-related pain intensity changes, adverse events and laboratory parameters.
• Study status:
  Finalised

Research institutions and networks

Institutions

Institute for Neurological Sciences (IFNAP)

Study timelines

Date when funding contract was signed

Planned: 07/01/2014

Actual: 07/01/2014

Study start date

Planned: 01/07/2015

Actual: 06/07/2015

Data analysis start date

Planned: 03/08/2015

Actual: 03/08/2015

Date of final study report

Planned: 31/12/2015

Actual: 29/01/2016

Sources of funding

Other

More details on funding

IFNAP, German Pain Association

Regulatory

• Was the study required by a regulatory body?:
  No